Outline

Introduction: Most research facilities especially in the preclinical divisions do not have quality management. Contrary, in clinical research official requirements are strictly regulated such as documentation, responsibilities and monitoring. Thus, most preclinical data cannot be translated in clinical trials or approval.

Materials and methods: Aiming at a higher confidence in preclinical research a quality management (QM) system, namely the DIN EN ISO9001:2000, was introduced. This QM system was chosen mainly because of the process orientation, the international acceptance and the annual external monitoring.

Results: The implementation of a QM system was time consuming and costly. However, 18 months after certification, the benefits for the preclinical research quality are already obvious. 1) Standardization and reproducibility: Over 300 standard operation procedures (SOPs), checklists and forms were developed, which are updated once a year. Laboratory equipment is regularly examined and staffs are well trained in its proper handling. 2) Project management: New comers in the research area are directed by an orientation guide, i.e. the QM handbook and a structured initial adaptation training. Projects follow a time line and milestone dependent project plan. A mentoring program supports new members in their daily work. Scheduled and recorded project discussions including data quality controls take place with the scientific group according to a meeting matrix. 3) Expertise: Competence of the staff including the students is continuously improved by specific training courses. Knowledge is further increased by weekly seminars, journal clubs and QM education. Interviews and surveys of the staff help to identify the individual needs.

Conclusion: A number of improvements are obtained in organisation, documentation, process flow and resource management in preclinical research by introducing quality management. Ongoing in the Plan-Do-Check-Act cycle will be an important approach in benchmarking and the translation of basic science in patient directed research.